What are regulations on classification of medical devices in Vietnam?

What are regulations on classification of medical devices in Vietnam?

Pursuant to Article 2 of the Circular 05/2022/TT-BYT stipulating classification of medical devices in Vietnam as follows:

1. A medical device or multiple medical devices shall be classified in order to determine level of risks and be granted registration number.

2. The classification of a medical device or multiple medical devices must rely on the rules for classification using A, B, C, D levels of risks (details are prescribed under Appendix I attached hereto).

3. Sample of medical device classification results shall conform to Appendix II hereof.

What are regulations on addition to the list of in vitro diagnostic medical devices that are not required to undergo quality inspection by Vietnam’s competent authorities?

Pursuant to Article 3 of the Circular 05/2022/TT-BYT stipulating addition to the list of in vitro diagnostic medical devices that are not required to undergo quality inspection by Vietnam’s competent authorities under Point dd Clause 3 Article 30 of Decree No. 98/2021/ND-CP as follows:

1. Granted Certificate of Free Sale by any of the following countries, organizations:

a) Food and Drug Administration (FDA) - United States of America;

b) Therapeutic Goods Administration (TGA) - Australia;

c) Health Canada;

d) Ministry of Health, Labour and Welfare (MHLW) - Japan;

dd) Pharmaceuticals and Medical Devices Agency (PMDA) - Japan;

e) National Medical Products Administration (NMPA) - China;

g) Ministry of Food & Drug Safety (MFDS) - Korea;

h) EU member states as per Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.

2. Granted registration number or certificate of registration, import permit for commercial purposes in Vietnam, except for cases where such items have been revoked.

3. Other than in vitro reagents, calibrators, control materials.

What are on the list of class B, class C, and class D medical devices purchased and sold as common commodities in Vietnam?

Pursuant to Article 4 of the Circular 05/2022/TT-BYT stipulating the list of class B, class C, and class D medical devices purchased and sold as common commodities in Vietnam under Clause 1 Article 42 of Decree No. 98/2021/ND-CP as follows:

1. Personal blood pressure monitors.

2. Fingertip pulse oximeter (SpO2).

3. Baby nasal aspirators.

4. Electronic thermometers, infrared thermometers.

5. Medical devices used to measure blood glucose: blood glucose monitoring device, lancing device, test strip, lancet, control solution, calibrators.

6. Nebulizers.

7. Medical tape, gauze pads.

8. Artificial tears classified as medical devices.

9. Condoms.

10. Vaginal contraceptive film (contains no drugs).

11. Vaginal lubricants classified as medical devices.

12. Electrical heating and cooling packs.

13. Class B in vitro diagnostic (ivd) medical device for self-testing.

14. In vitro diagnostic (ivd) medical device for self-testing of HIV, SARS-CoV-2.

What are on the list of medical equipment to be inspected for safety and technical functions in Vietnam?

Pursuant to Article 5 of the Circular 05/2022/TT-BYT stipulating the list of medical equipment to be inspected for safety and technical functions in Vietnam under Clause 10 Article 70 of Decree No. 98/2021/ND-CP as follows:

1. Ventilators.

2. Anaesthetic machines.

3. Electric scalpels.

4. Infant incubators.

5. Defibrillators.

6. Hemodialysis machines.

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